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    Summary
    EudraCT Number:2009-012786-58
    Sponsor's Protocol Code Number:8-79-52014-168
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2009-012786-58
    A.3Full title of the trial
    Prostate cancer antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) score changes during initiation of androgen deprivation therapy (ADT) with triptorelin 22.5mg in patients with advanced prostate cancer (PCa): a phase III, single arm multicentre study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to access the change in the score of two biomarkers in patients who are begining treatment with androgen deprivatin therapy (Triptorelin 22.5mg) that have advanced prosate cancer.
    A.3.2Name or abbreviated title of the trial where available
    TRIPTOCARE
    A.4.1Sponsor's protocol code number8-79-52014-168
    A.5.4Other Identifiers
    Name:n/aNumber:n/a
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTriptorelin-6-month
    D.3.2Product code 52014
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic prostate cancer
    E.1.1.1Medical condition in easily understood language
    For the treatment of cancer that has spread to area just outside of the prostate gland and for treatment of cancer that has also spread to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To model the PCA3 score changes at 6 months post-treatment using a multivariate linear model and the following variables outcomes at baseline: age, prostate specific antigen (PSA), clinical stage (TNM), pathological grade (Gleason score) and T2-ERG score.
    E.2.2Secondary objectives of the trial
    To model the PCA3 score change at 1-month and 3-month post treatment using a similar model as described above.
    To assess the 6-month post treatment time profile of PCA3 score changes.
    To perform a descriptive analysis of T2-ERG (at baseline, 1-month, 3-month and 6-month post-treatment).
    To assess the 6-month post-treatment time profile of T2-ERG score changes.
    To assess the clinical efficacy and safety of triptorelin 22.5mg over a 6-month treatment period.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PROSTATE CANCER ANTIGEN-3 (PCA-3) AND TMPRSS2-ERG (T2-ERG) SCORE CHANGES DURING INITIATION OF ANDROGEN DEPRIVATION THERAPY (ADT) WITH TRIPTORELIN 22.5MG IN PATIENTS WITH ADVANCED PROSTATE CANCER (PCA): A PHASE III, SINGLE ARM MULTICENTRE STUDY.

    RETROSPECTIVE CENTRALIZED PATHOLOGY REVIEW

    Objective : central evaluation of the Gleason score by a unique pathologist to standardize the interpretation of the prostate biopsies
    E.3Principal inclusion criteria
    All patients must fulfil the following:
    Patients must give written (personally signed and dated) informed consent before completing any study-related procedure.
    Patients must be 18 years old or over.
    Patient must have a histologically confirmed, locally advanced or metastatic prostate cancer, and be naive to androgen deprivation therapy, and be candidate for hormonal treatment.
    Patient must have an estimated survival time of at least twelve months according to the investigator's assessment.
    Patient must have a performance status score ≤ 2 according to the WHO criteria.
    E.4Principal exclusion criteria
    Patients will not be included in the study if:
    The patient with no risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy).
    The patient has had previous surgical castration.
    The patient has had previous or has planned curative prostate cancer therapy (radiation/surgery).
    The patients has had previous hormone therapy (GnRH analogues, estrogens or anti-androgens).
    The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or presents any concomitant condition which cold compromise the objectives of hte study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastasis, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
    Patient who have received investigational drug or treatment within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments.
    Diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin.
    Known hypersensitivity to triptorelin, GnRH, other GnRH agonist analogues or analogues to an excipients of the IMP.
    E.5 End points
    E.5.1Primary end point(s)
    PCA3 score expressed as a ratio of PCA3 mRNA over PSA mRNA
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6-month post treatment
    E.5.2Secondary end point(s)
    See section on Secondary objectives
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 315
    F.4.2.2In the whole clinical trial 315
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who complete or withdraw from the study will be subsequently treated at the discreation of the Investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-02
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